Reattachment of the SPR Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation

July 8, 2021 updated by: Peking University Third Hospital

The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation

Clinical outcomes between reattachment of the superior peroneal retinaculum (SPR) and the bone block procedure were compared in this study to elucidate which procedure was safer and more effective.

Study Overview

Detailed Description

From 2012 to 2016, 25 patients with recurrent peroneal tendon dislocation underwent the bone block procedure(group A), and another 22 patients underwent reattachment of the SPR (group B). American Orthopaedic Foot and Ankle society (AOFAS) ankle-hindfoot score, Ankle Activity Score (AAS), time to return to sports activity, rate of return to sports level, range of motion (ROM) of the ankle, rate of recurrence, and overall patient satisfaction were collected to evaluate outcomes between the two groups.

Study Type

Observational

Enrollment (Actual)

47

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A consecutive series of patients with recurrent peroneal tendon dislocation who underwent operative treatment between 2012 and 2016 were retrieved. Twenty-five patients underwent bone block procedure (group A), and 22 patients underwent reattachment of the SPR (group B)."

Description

Inclusion Criteria:

  • a traumatic recurrent peroneal tendon dislocation requiring surgery
  • a lack of response to at least 3 months of conservative treatment

Exclusion Criteria:

  • the presence of an acute peroneal tendon dislocation
  • a concomitant anterior talofibular ligament rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bone block procedure
patients with recurrent peroneal tendon dislocation underwent the bone block procedure
a 20 × 15 × 3 mm3 bone block was cut from the lateral malleolus, rotated backwards 45°, and sutured back to the periosteum of the lateral malleolus using non-absorbable sutures.
Reattachment of the superior peroneal retinaculum
patients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum
two suture anchors (Mini Quickanchor,DePuy Mitek) were inserted into the postero-lateral ridge of the lateral malleolus without damaging the cartilaginous ridge, after which the SPR was reattached to the lateral malleolus with the anchored suture. The inner layer of the false pouch was incised, and the outer layer (periosteum) was sutured with the SPR in a pants-over-vest style.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS
Time Frame: 2 years after operation
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
2 years after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 2 years after operation
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
2 years after operation
time to return to sports activity
Time Frame: up to 2 years
time to return to sports activity after surgery at each group
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Qinwei Guo, MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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